Hypertension,EssentialNCT05462535
An Observational Study to Evaluate Effectiveness and Safety of Amosartan Plus Tablet
An observational study of Hypertension,Essential, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients. During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Amosartan Plus Tab.
- How many people
- 4,785 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2018to 15 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Uncontrolled essential hypertension patients
Who may be able to join
- Uncontrolled essential hypertension patients
- Those who have already decided to administer Amosartan Plus tablet under the medical judgment of the researcher
- Those who voluntarily decided to participate in this study and consented in writing to the consent form
Who cannot join
- Patients for whom use of Amosartan Plus tablet is prohibited
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Evaluate the Efficacy and Safety of Amosartan Plus Tablet in Uncontrolled Essential Hypertension Patients
This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients.
During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment.
Read more
In this study, effectiveness and safety information of treatment of Amosartan Plus tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.
As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.
Read the detailed description
This study was a multi-center, prospective, non-interventional, observational study of factors affecting blood pressure after treatment with Amosartan Plus tablet in uncontrolled essential hypertension patients.
Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Plus tablet.
This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.
- Conditions
- Hypertension,Essential
- Being tested
- Amosartan Plus Tab.
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amosartan Plus Tab.Drug
Also called Amlodipine camsylate, Losartan potassium, Chlorthalidone
Amosartan Plus Tab., Once daily administered per the locally approved product information
| Study group | Role | What they receive |
|---|---|---|
| Single arm, Single group(No interventional) | Observational Receives: Drug: Amosartan Plus Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in SBP/DBP
Measured: 24 weeks
Percentage from baseline in SBP/DBP
Measured: 24 weeks
Percentage of patients achieving target blood pressure
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start26 Feb 2018
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4,785 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462535
- Sponsor's protocol ID
- HM-AMOP-OS-01
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Efficacy and Safety of Amosartan Plus Tablet in Uncontrolled Essential Hypertension Patients
- ClinicalTrials.gov ID
- NCT05462535
- Acronym / sponsor ID
- HM-AMOP-OS-01
- Conditions
- Hypertension,Essential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,785 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients.
During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment.
In this study, effectiveness and safety information of treatment of Amosartan Plus tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.
As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.
Detailed description
This study was a multi-center, prospective, non-interventional, observational study of factors affecting blood pressure after treatment with Amosartan Plus tablet in uncontrolled essential hypertension patients.
Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Plus tablet.
This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, Single group(No interventional) | – | Drug: Amosartan Plus Tab.Observational |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Uncontrolled essential hypertension patients
Key inclusion criteria (3 listed)
- Uncontrolled essential hypertension patients
- Those who have already decided to administer Amosartan Plus tablet under the medical judgment of the researcher
- Those who voluntarily decided to participate in this study and consented in writing to the consent form
Key exclusion criteria (1 listed)
- Patients for whom use of Amosartan Plus tablet is prohibited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amosartan Plus Tab.Also: Amlodipine camsylate, Losartan potassium, ChlorthalidoneAmosartan Plus Tab., Once daily administered per the locally approved product information | Drug | Single arm, Single group(No interventional) |
Primary outcome
Change from baseline in SBP/DBP
Time frame: 24 weeks
Percentage from baseline in SBP/DBP
Time frame: 24 weeks
Percentage of patients achieving target blood pressure
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in SBP/DBP (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.